Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

February 14, 2023 updated by: Alfredo Martinez, Fundacion Rioja Salud

Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

Stroke is one of the leading causes of death and disability worldwide. More than 85% of strokes are due to blood vessel occlusion resulting in partial destruction of the brain parenchyma. Current protocols try to re-establish blood circulation as soon as possible through chemical and/or mechanical interventions but new strategies are needed.

Periodic acceleration (pGz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). Application of pGz in an animal model of stroke resulted in a dramatic reduction of associated brain damage.

This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Periodic acceleration (pGz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). Application of pGz in an animal model of stroke resulted in a dramatic reduction of associated brain damage.

This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Hospital San Pedro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A signed informed consent form must be obtained prior to recruitment
  • Patients with symptoms of acute ischemic stroke
  • Less than 12 hours from initiation of the stroke
  • Age: 18 years or older
  • Capable of following the protocol

Exclusion Criteria:

  • Pregnant or lactating women, and women that do not follow a contraceptive plan and may become pregnant
  • Less than 18 years of age
  • More than 12 hours from the initiation of the stroke or when the initiation time is unknown.
  • Hemorrhagic stroke
  • Candidates to receive thrombolytic treatment
  • Spine traumatism or other conditions that may be aggravated by pGz
  • Patients that cannot be properly followed because of phycological, social, familiar, or geographical reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Static group
Control group. They will receive the standard care provided by the protocols of the ictus unit. They will lay on the Exer-Rest® TL device but the acceleration will NOT be connected.
Device: Exer-Rest® TL
Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
Experimental: Single pGz intervention
In addition to the standard care established in the ictus unit, these patients will receive a single exposure to pGz on the Exer-Rest® TL, for 3 hours, during the first day of their stay in the hospital.
Device: Exer-Rest® TL
Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
Experimental: Multiple pGz interventions
In addition to the standard care, these patients will be exposed to 45 minutes of pGz, on the Exer-Rest® TL, every day during their first week in the Hospital.
Device: Exer-Rest® TL
Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS and Rankin scales
Time Frame: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds
The NIHSS and Rankin scales will be applied to the patients at the indicated times
0hr, 2hr, 24hr, 48hr, 7ds, 90ds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct volume
Time Frame: 7 days
Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood markers
Time Frame: 0, 1, 3, 5, and 7ds
Neuroprotective substances that can be released by pGz (nitric oxide, tissue plasminogen activator, adrenomedullin, prostaglandins, etc) will be measured in the blood of patients to investigate the efficacy of the treatment.
0, 1, 3, 5, and 7ds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Rioja Salud

Collaborators

Hospital San Pedro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

December 30, 2013

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBIR002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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